A New Birth Weight Prediction in Chinese Population

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Birth Weight

Treatments: Diagnostic Test: 2D and 3D ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT03223363

LC2016PY021

Details and patient eligibility

About

To determine the value of principal component analysis in the combined method of three-dimensional ultrasonography assessing fetal limb volume and circumference and conventional two-dimensional ultrasonography for prediction of birth weight in southern Chinese population.

Full description

A prospective study was performed on single pregnant women in third trimester. Three- and two-dimensional ultrasonography for fetal biometric parameters were measured within 7 days of delivery. Stepwise linear regression were used to develop a new prediction model based on values from limb parameters and traditional measurements in development group. Estimated and actual birth weight were compared between the new model and previously published formulas on absolute error and percentage error. The accuracy of the model in predicting fetal birth weight was reassured by validation group.

Enrollment: 10,000 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The inclusion criteria consisted of well-defined gestational age (GA), singleton pregnancy and delivery in our hospital within 7 days from the scan performed for acquisition of 2D and 3D ultrasonographic data.

Exclusion criteria

• The exclusion criteria were equivocal GA, multiple pregnancy, fetal severe malformation detected by prenatal ultrasonographic scans, delivery more than 7 days after the scan of 2D and 3D ultrasonography, and delivery in other institutions.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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10,000 participants in 2 patient groups

Development Group

Experimental group

Description:

Development Group is used to establish the prediction model.2D and 3D ultrasonography are performed in this group. Through statistical analysis we obtain a new model.

Treatment:

Diagnostic Test: 2D and 3D ultrasonography

Validation group

Other group

Description:

Validation Group is used to confirm the efficacy of the prediction model.2D and 3D ultrasonography are performed in this group.Absolute and percentage error are calculated and compared with a common formula to confirm the accuracy of this new model.

Treatment:

Diagnostic Test: 2D and 3D ultrasonography